NCT01297803

Brief Summary

Application of antimetabolite agents such as mitomycin\_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin\_c can be applied remain a concern before or after sclera flap dissection. Mitomycin\_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin\_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin\_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 17, 2011

Status Verified

November 1, 2010

Enrollment Period

7 months

First QC Date

January 19, 2011

Last Update Submit

February 16, 2011

Conditions

Glaucoma Patients Scheduled for Trabeculectomy

Outcome Measures

Primary Outcomes (3)

  • corneal endothelial cell density

    specular microscopy

    six month

  • corneal endothelial cell polymorphism

    specular microscopy

    6 months

  • corneal endothelial cell polymegathism

    specular microscopy

    6 months

Secondary Outcomes (1)

  • IOP (intra ocular pressure)

    six months

Study Arms (2)

Mitomycin_c application before sclera flap dissection

ACTIVE COMPARATOR
Drug: Mitomycin_c

Mitomycin_c application after sclera flapdissection

ACTIVE COMPARATOR
Drug: Mitomycin_c

Interventions

Mitomycin_cDRUG

0.02%.1,2,3,minutes match randomized in to two groups(before \&after scleral flap dissection

Mitomycin_c application before sclera flap dissection

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age Range between 18 to 80 years old
  • Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome.

You may not qualify if:

  • Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Labbafinejad medical center

Tehran, Iran

RECRUITING

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2011

First Posted

February 17, 2011

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

February 17, 2011

Record last verified: 2010-11

Locations

IR(1)